UNKN PATIENT POSITIONER

Additional Manufacturer Narrative

H3,H6: THE REPORTED DEVICE, USED IN TREATMENT WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. NO PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW AND COMPLAINT HISTORY COULD NOT BE CONDUCTED . A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE FOOT CONTINUED TO SLIP OUT OF THE SUPINE HIP POSITIONING SYSTEM DUE TO THE SIZE OF THE PATIENT. THE FOOT WAS SMALL SO WHEN TRACTION WAS APPLIED THE FOOT SLIPPED AND LOST THE SPACE WITHIN THE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY, THE FOOT CONTINUED TO SLIP OUT OF THE SUPINE HIP POSITIONING SYSTEM DUE TO THE SIZE OF THE PATIENT. THE FOOT WAS SMALL SO WHEN TRACTION WAS APPLIED THE FOOT SLIPPED AND LOST THE SPACE WITHIN THE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.